New therapies show promise in treating diabetes

Diabetes medications were the most expensive traditional therapy drugs in 2016, with an overall trend of 19.4%, according to the latest Express Scripts drug trend report. This positive trend is reflective of increases in both utilization and cost.

Here’s how pipeline developments could change the landscape.

Pipeline treatments

Peterson

“While I do not see any game-changing medications within the diabetes class that will reach the market within the next several years, there are a few updates that we are watching,” says Chris Peterson, director in the emerging therapeutics department at Express Scripts.

He points to the continued growth of the sodium-dependent glucose cotransporter-2 (SGLT-2) inhibitor class-sparked by the positive cardiovascular outcomes from empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly), a previously approved SGLT2 inhibitor. Pipeline SGLT-2 inhibitors include investigational ertugliflozin (Merck and Pfizer) and bexagliflozin (Chugai Pharma), both in phase 3 development at press time. Sotagliflozin (Lexicon Pharmaceuticals), a first-in-class oral dual SGLT-1 and SGLT-2 inhibitor for type 1 and type 2 diabetes, also in phase 3. If approved, it will be the first oral drug approved for type 1 diabetes, a disease that typically has been managed by lifestyle modifications and insulins, says Farrah Wong, PharmD, director, pipeline and drug surveillance at OptumRx.

The glucagon-like peptide-1 (GLP-1) analog class is also expected to grow, says Peterson. This is driven by cardiovascular outcomes data with liraglutide (Victoza, Novo Nordisk) and the introduction of the fixed-dose combination GLP-1 agonist/long-acting insulin products, insulin glargine and lixisenatide injection (Soliqua 100/3, Sanofi) and insulin degludec/liraglutide (Xultophy, Novo Nordisk).

Semaglutide is a GLP-1 agonist in development for glycemic control in patients with type 2 diabetes. It is being developed as both subcutaneous formulation from Novo Nordisk and oral form from Novartis. If approved, it will be the first oral GLP-1 agonist on the market.

“As oral drugs are easier to administer and less invasive than injectable drugs, oral semaglutide may offer these advantages over other GLP-1 agonists,” says Wong. “Furthermore, type 2 diabetics will have another oral therapeutic option in a class of drugs that thus far were only injectable drugs.”

Exenatide osmotic mini-pump (ITCA 650, Intarcia Therapeutics, Inc.) is a subcutaneous implant that continuously delivers the GLP-1 agonist, exenatide, for three months (introductory dose) or six months (maintenance dose) to treat type 2 diabetes. Approval is expected in November 2017, says Peterson.

New insulin products are also expected to receive approval soon, including insulin tregopil (Biocon Ltd.), an oral insulin in phase 2 development for type 1 and type 2 diabetes.

“Currently, insulins are either injected or inhaled,” says Wong. “If an oral insulin product is available, the ease of administration may drive some of the market share to shift from injectable/inhaled insulins to the oral product.”

Insulin glargine injection (Basaglar, Eli Lilly/Boehringer Ingelheim) approved last year, was the first “follow-on” insulin glargine product to treat diabetes. Another “follow-on” insulin glargine product, known as MK-1293 (Merck/Samsung Bioepis), will be competing as a brand product within the market and is expected to be approved in the second quarter of 2017. Basalog is yet another insulin glargine product currently in phase 3 development; however, it is not yet clear whether the manufacturer, Mylan, will seek approval as a competing brand or as a generic to Lantus (Sanofi). Finally, Sanofi is developing SAR342434, a follow-on protein to Lilly's Humalog (insulin lispro), for the treatment of diabetes mellitus. If approved, it will compete as a brand with the other rapid-acting insulins.

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